N/A
N=43
EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA
Breast Cancer Female
Bottom Line
View on ClinicalTrials.gov: NCT05747209 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Session Attendance — 39 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observation of Exercise Program Adherence (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Colin Champ, MD
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Session Attendance |
39 | — |
| PRIMARY Change in Adipose Tissue (InBody, kg) |
30.7; 28.2 | — |
| PRIMARY Change in Adipose Tissue (Ultrasound, Lbs) |
37.4; 32.6 | — |
| PRIMARY Change in Muscle Mass |
25.0; 25.6 | — |
| PRIMARY Change in Fat-Free Mass |
45.9; 46.9 | — |
| PRIMARY Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels |
5; 5; 5; 5; 5; 5 | — |
| PRIMARY Activity Levels Via Godin Questionnaire |
23.5; 41.5 | — |
| PRIMARY Resting Metabolic Rate as Calories Burned Per Day |
1365.5; 1381.5; 1403; 1437 | — |
| PRIMARY Functional Movement Screen |
9; 12 | — |
| PRIMARY Y-balance Score |
72.3; 83.9; 73.0; 86.2 | — |
| PRIMARY Changes in Strength From Baseline Through Study Completion, up to 3 Months |
192; 383; 383; 1131; 1210; 1415 | — |
| SECONDARY Participants Will Undergo an Assessment 1 Year Following the Exercise Program. |
— | — |
Summary
The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:
* Is resistance training feasible following breast cancer treatment
* Can it improve the body's mobility and strength lost as a result of the breast cancer treatment
* can it improve the body's composition (for example muscle mass)
* can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.
Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.
Eligibility Criteria
Inclusion Criteria
- Age 20-89 years
- Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
- Participants must have abstained from smoking for at least 12 months
- Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
- Participants must be determined capable of engaging in resistance training.
- Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
- Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel.
- Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI
- Participants must be able to get down and up from the ground and squat their body weight.
Exclusion Criteria
- Any treatment with chemotherapy for breast cancer
- Inability to get and down off the ground or squat body weight
- Inability to safely engage in group sessions
- Severe arthritic, joint, cardiovascular, or musculoskeletal condition
Data sourced from ClinicalTrials.gov (NCT05747209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.